Study on Talazoparib for Treating Advanced or Metastatic Cancers with BRCA Gene Changes

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02286687

Provider View

This clinical trial is testing how well the drug talazoparib works in patients with advanced cancers that have returned, don't respond to treatment, or have spread, and have changes in the BRCA genes. Talazoparib may help kill cancer cells by blocking an enzyme that protects them.

Patient Parameters

Program Overview

This Phase II study is exploring the effectiveness of talazoparib in treating patients with advanced cancers that have returned, are resistant to treatment, or have spread to other parts of the body, and have changes in the BRCA genes. Talazoparib works by blocking an enzyme that helps protect cancer cells, potentially leading to their death.

Description

The main goal of this study is to see if talazoparib can provide clinical benefits, such as shrinking tumors or stopping them from growing, in patients with advanced or metastatic cancers that have specific changes in the BRCA genes. These changes can include mutations or deletions in BRCA1 or BRCA2, or other related genes. The study also aims to evaluate the safety of talazoparib and identify any markers that might predict how well the treatment works.

Participants will take talazoparib by mouth once a day in 28-day cycles, continuing as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will have follow-up visits 30 days later and then every 12 weeks for a year.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic cancer that has not responded to standard treatments or has returned after treatment.
  • Have specific genetic changes in BRCA1 or BRCA2, or other related genes.
  • Have measurable cancer according to standard criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Be at least four weeks past any previous cancer treatments.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 120 days after the last dose.
  • Be able to understand and sign an informed consent form.
  • Have cancer that can be biopsied, unless you have a germline BRCA alteration and are eligible for a specific cohort.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Previous treatment with a PARP inhibitor.
  • Known infections like hepatitis B, hepatitis C, or HIV.
  • Difficulty swallowing pills.
  • Active infections needing IV antibiotics or other serious illnesses requiring hospitalization.
  • Medical conditions affecting drug absorption, like certain surgeries or digestive issues.
  • Inability to follow study procedures.
  • Recent history of stroke, heart attack, or unstable chest pain.
  • Other active cancers needing treatment, except for certain skin cancers or in situ cervical cancer.
  • Psychiatric or substance abuse issues affecting study participation.
  • Active brain metastases or cancer in the brain lining, unless previously treated and stable.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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